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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Integrated Medical Systems Inc: If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Agency Publication Date: February 25, 2016
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Affected Products

Product: Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope

Serial Numbers: 2005030,2800270,2007268,2802306,2802294,2108696,2801707,2006928,2201349,2904573, 2108936,2006513,2107568,2801235,2800468,2200301,2006896,2802237,2802245,2109496, 2109225,2006520,2200358,2200372,2200370,2200350,2200356,2200364,2200351,2200345, 2005915,2109239,2109237,2904265,2108385,2100007,2904378,2801427,2200930,2107811, 2700057,2004864,2004924,2800273,2109999,2100088,2301603,2107560,2200701,2200648, 2904362,2802353,2802234,2801828,2801792,2903393,2903491,2109241,2109087,2109090, 2201179,2109261,2109234,2802808,2801887,2801892,2007452,2801960,2006598,2903718, 2007242,2007253,2903751,2006554,2006560,2802465,2007275,2004893,2802541,2903876, 2903913,2200971,2700124,2904046,2904425,2007142,2802500,2904240,2109319,2800517, 2802466,2802455,2200168,2006418,2200172,2006479,2108689,2201411,2201402,2005274, 2005123,2005141,2201410,2201389,2903348,2800505,2006883,2801725,2200481,2903648, 2903632,2108188,2108969,2109228,2109233,2802031,2802017,2802028,2802016,2802029, 2108350,2108320,2801583,2903806,2904150,2007033,2903029,2802758,2802794,2802793, 2005497,2005545,2700076,2903964,2903965,2903969,2201427,2100108,2007401,2802654, 2005642,2802394,2903060,2903059,2903756,2200703,2200988,2201112,2903499,2904701, 2802756,2005665,2800338,2108452,2100110,2201023,2301893,2301911,2904358,2904345, 2904344,2904356,2904336,2802111,2005706,2005255,2200750,2200766,2200880,2200769, 2200774,2005599,2802920,2006131,2006639,2006641,2006642,2006638,2006640,2006632, 2006628,2006635,2006634,2903927,2005006,2904212,2903346,2802333,2904016,2903343

Product: Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope

Serial Numbers: 2003035,2704738,2704724,2809007,2808939,2105965,2808765,2004365,2004669,2902353, 2902347,2902342,2004663,2602122,2105267,2601317,2806231,2805648,2808714,2807053, 2807205,2705548,2806959,2704571,2704560,2704611,2705574,2805740,2004809,2703149, 2601037,2901878,2702879,2702870,2703000,2704441,2902854,2003990,2003988,2705078, 2004004,2702967,2808478,2809057,2601256,2601255,2808955,2808944,2807181,2809202, 2206863,2900222,2900226,2900745,2901670,2900229,2003063,2902820,2002897,2600226, 2602014,2003460,2900362,2900112,2806936,2003147,270517S,2704934,2909893,2909872, 2909863,2901323,2806640,2704259,2106188,2106273,2601745,2704573,2003712,2807584, 2807557,2807713,2106293,2106290,2106303,2106300,2807679,2704771,2704770,2704792, 2704800,2602187,2704885,2808319,2602175,2808317,2602190,2702863,2808937,2809103, 2901274,2002984,2002916,2901389,2901374,2601611,2805999,2004421,2704766,2703778, 2705367,2795393,2805917,2805916,2809093,2902295,2004720,2902215,2809055,2004871, 2705449,2809016,2809050,2808936,2808938,2805816,2809044,2900211,2901687,2601179, 2602413,2704897,2705037,2808546,2808581,2808537,2808530,2004462,2004461,2004458, 2004457,2004452,2900338,2806650,2900337,2704236,2704202,2806696,2902604,2703089, 2601468,2004949,2702732,2602089,2808410,2808402,2808413,2808391,2808412,2808415, 2808405,2808379,2807126,2705106,2805727,2702820,2705110,2702954,2704316,2103301, 2901080,2901329,2901326,2900094,2807461,2807463,2600468,2600432,2600183,2003532, 2602342,2901759,2901798,2901789,2901786,2004023,2004047,2601355,2206691,2807571, 2601721,2900252,2808516,2809385,2809049,2809068,2809056,2809060,2806692,2806772, 2702822,2807586,2703753,2106008,2902452,2704036,2601438,2703138,2601515,2703127, 2703134,2105807,2806871,2806863,2003144,2902409,2806880,2809409,2703670,2900905, 2900885,2900901,2900907,2900902,2900892,2902465,2105610,2600472,2602482,2004043, 2909906,2808548,2602237,2901669,2900507,2705345,2703372,2600645,2003099,2807855, 2806888,2807784,2807852,2704075,2900761,2806646,2900595,2809208,2902564,2600735, 2003799,2601893,2602481,2003728,2003726,2900894,2808085,2808064,2808060,2900874, 2003167,2105243,2909945,2601918,2809264,2909796,2909798,2004189,2704407,2901872, 2808189,2808188,2600417

Product: Olympus, Model No. CF-H180AL, flexible scope, large diameter, video colonoscope

Serial Numbers: 2601800,2807942,2104002,2807968,2003519,2003522,2003506,2003533,2003517,2807849, 2807869,2106004,2001560,2602147,2806411,2900360,2001561,2602228,2602229,2309559, 2309556,2602230,2805615,2103724,2103717,2002975,2805586,2806264,2806591,2705038, 2908746,2808043,2704335,2705017,2002983,2106012,2105987,2106009,2106019,2002580, 2002571,2104510,2002603,2900105,2001677,2105162,2909901,2703303,2909972,2601007, 2601084,2104893,2704419,2806374,2806356,2104903,2908799,2601095,2807327,2640009, 2702843,2207664,2207660,2702782,2106428,2806318,2908674,2702730,2704143,2703560, 2106031,2908845,2908846,2908841,2908838,2908852,2908837,2908840,2908843,2106106, 2601525,2807589,2808233,2309810,2805782,2909109,2601535,2104776,2104781,2806163, 2908908,2103829,2104924,2002427,2909718,2002323,2703941,2601588,2601200,2600263, 2309366,2602033,2602034,2900148,2106202,2003379,2000851,2003280,2106797,2003653, 2106800,2807548,2106791,2909657,2003008,2003228,2003232,2106134,2808000,2900241, 2900656,2000774,2106423,2003189,2106410,2309513,2900683,2106413,2807888,2309493, 2106264,2106409,2106422,2107166,2909809,2107149,2808271,2702536,2702344,2704544, 2704568,2704587,2703158,2104281,2703144,2602024,2002832,2805717,2002833,2600272, 2704020,2001762,2207531,2900586,2003128,2208594,2002620,2309683,2001688,2104750, 2104891,2309573,2000881,2309635,2001645,2001650,2106010,2104981,2104993,2104937, 2104890,2900413,2703200,2601190,2309828,2909966,2601218,2001712,2601205,2806343, 2704399,2704716,2105584,2105562,2105559,2104847,2601672,2601642,2602223,2808051, 2703078,2002521,2601938,2601866,2908548,2908499,2105744,2909315,2105988,2106017, 2309497,2309262,2104662,2806423,2105002,2105542,2001423,2309783,2703663,2703654, 2001547,2600215,2001708,2001468,2001514,2001519,2309845,2001311,2309105,2208046, 2208058,2806987,2704187,2208651,2309470,2003116,2003086,2003104,2208215,2001850, 2805888,2309542

Product: Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope

Serial Numbers: 2203925,2001221,2205721,2102757,2102758,2000420,2419219,2001053,2001248,2001285, 2103701,2307844,2408213,2419900,2419587,2419391,2307188,2408135,2408138,2205035, 2205321,2306154,2103419,2000710,2408319,2103515,2204385,2204384,2510491,2419538, 2001154,2103711,2101909,2306353,2103416,2000041,2103345,2408554,2408663,2307057, 2103617,2419115,2306153,2205297,2205019,2306510,2419520,2000431,2408693,2205441, 2419920,2204907,2102886,2102877,2306758,2306495,2000590,2510424,2205820,2307047, 2307014,2307030,2307052,2307066,2306132,2204209,2204663,2204110,2419379,2205371, 2205380,2205384,2408566,2204782,2103708,2101363,2419549,2001300,2103162,2103161, 2510637,2419320,2204264,2204882,2408764,2408487,2419319,2510526,2204325,2419745, 2204606,2103269,2102524,2419255,2419198,2204551,2000906,2307366,2307304,2103274, 2510151,2419258,2102792,2307251,2102786,2307350,2419462,2407416,2306959,2306800, 2307470

Product: Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope

Serial Numbers: 2102433,2102439,2102434,2002026,2002023,2000101,2000567,2001703,2317892,2001252, 2103738,2206336,2001183,2317780,2317782,2001658,2002113,2002108,2001058,2205716, 2103267,2206418,2104707,2104698,2000541,2001445,2000352,2104483,2104215,2001040, 2104379,2104209,2103329,2103015,2104488,2102974,2206175,2001272,2001664,2001241, 2317793,2105371,2001462,2418248,2418397,2105032,2418202,2001127,2001130,2206216, 2104357,2104490,2103447,2205654,2103446,2103440,2205664,2001504,2001507,2104514, 2001451,2104498,2104528,2104474,2001880,2001877,2104733,2104747,2104736,2104746, 2206304,2001661,2001630,2001629,2001626,2001641,2104502,2206298,2104780,2104768, 2104772,2317557,2001884,2317515,2104773,2105392,2205478,2105396,2205463,2205479, 2102775,2217033,2217029,2217036,2104347,2002170,2206318,2317401,2317975,2103228, 2317752,2216831,2317699,2317693,2317691,2103700,2103695,2104487,2104491,2103098, 2103009,2103295,2104653,2317589,2104541,2002004,2002001,2104533,2001862,2103606, 2103935,2104349,2000395,2103657,2317957,2000953,2206569,2103744,2217195,2002120, 2317577,2104489,2103049,2317690,2103060,2317683,2317684,2103375,2000500,2216960, 2000389,2000634,2105256,2105255,2105150,2317905,2317875,2103770,2103557,2103574, 2216820,2217126,2217122,2206257,2206237,2206196,2206239,2206200,2206049,2001713, 2206052,2206240,2001536,2317519,2216863,2102463,2102459,2102464,2102474,2001783, 2001781,2001788,2001747,2001770,2001778,2001756,2001755,2001785,2105103,2001731

Product: Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope

Serial Numbers: 2501321,2603572,2603751,2707414,2500011,2705546,2604232,2603079,2500780,2808458, 2001720,2002054,2001724,2001723,2501905,2809593,2705417,2500916,2808421,2809413, 2705911,2203846,2808998,2501295,2809000,2705264,2603152,2809444,2706645,2102694, 2203503,2809061,2705453,2706361,2102880,2002142,2500236,2705566,2705242,2500869, 2501511,2603466,2706515,2706908,2706905,2706442,2001193,2501087,2501807,2705697, 2705333,2900664,2501186,2800014,2707065,2705978,2501786,2002139,2002083,2809935, 2809951,2707769,2304352,2707593,2304332,2001807,2808518,2602866,2602846,2706687, 2001864,2808509,2705957,2706072,2705888,2602226,2102504,2501901,2501941,2900354, 2501928,2203680,2500463,2203472,2707126,2603744,2707886,2901047,2603180,2604176, 2707760,2502049,2602102,2706079,2706071,2603287,2602732,2602730,2900859,2705386, 2808456,2705662,2809750,2705605,2705589,2808232,2706404,2500529,2602714,2501738, 2706823,2809590,2604997,2604999,2604989,2808704,2808713,2604264,2706028,2800064, 2808452,2500660,2501776,2808455,2501961,2501854,2809540,2501472,2602442,2603316, 2808333,2707097,2706919,2707574,2501001,2706156,2605035,2501890,2603001,2603053, 2706604,2707840,2501962,2605156,2808499,2304527,2603134,2604932,2102468,2500067, 2501704,2501595,2603135,2705891,2807973,2705461,2603530,2707882,2706068,2807964, 2706013,2705465,2707101,2705475,2707892,2500032,2602610,2501680,2707346,2707374, 2707382,2500458,2500653,2808341,2808894,2603444,2001317,2602502,2604160,2500576, 2706920,2808353,2705694,2705593,2900826,2900764,2604623,2901059

Product: Olympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscope

Serial Numbers: 2000023,2110370,2211004,2210975,2110666,2110583,2411739,22109S9,2311220,2812668, 2311177,2110498,2411568,2110745,2110711,2000181,2211040,2812506,2110504, 2311372,2012921

Product: Olympus, Model No. CF-Q180AL, flexible scope, large diameter, video colonoscope

Serial Numbers: 2807123,2706168,2704697,2704696,2706205,2603823,2500832,2806683,2706253, 2706256,2704313,2704314,2008421,2602202,2602873,2806818,2704323,2603826, 2806676,2807264,2603013,2602S15,2501708,2806563,2501622,2602650,2501251, 2704932,2501637,2705315,2208812,2603725,2806595,2601980,2500885,2603935, 2705615,2705705,2705305,2500522,2907865,2705498,2603941,2807163,2807143, 2501819,2704886,2501553,2501744,2501768,2603178,2603044,2704755,2501372, 2807593,2705425,2208838,2208833,2706176,2008309,2704655,2705847,2706206, 2603321,2705005,2501169,2704832,2704839,2602446,2806333,2705983,2500287, 2601941,2501912,2604229,2501770,2806741,2806744,2603057,2704336,2806592, 2500217

Product: Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope

Serial Numbers: 2123053,2337714,2338700,2337727,2112612

Product: Olympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscope

Serial Numbers: 2000158, 2203109,2000413,2101113,2304140,2203874,2405424,2203295,2203853, 2517622,2101047,2102290,2102302,2102305,2102303,2203697,2102317,2102297, 2202898,2203059,2203471,2304922,2202617,2416261,2102141,2101633

Product: Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope

Serial Numbers: 2813102,2914792,2711389,2711291,2812266,2812356,2802476,2600371,2914632, 2914333

Product: Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope

Serial Numbers: 2801185,2801376,2700216,2903833,2903851,2700830,2801154,2700481,2700049, 2025259,2802540,2700325

Product: Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope

Serial Numbers:2707306,2705876,2807674,2706579,2009538,2706717,2604531,2706710,2501499, 2808113,2705777,2705730,2707016,2808779,2808777,2707125,2603799,2603795, 2603779,2603825,2604265,2807420,2604568,2501361,2500180,2602289,2909274, 2808355,2808217,2808957,2808020,2602290,2707346,2707406,2808556,2807468, 2603295,2604460,2705711,2009462,2602564,2501493,2808528,2500150,2603952, 2603243,2807523,2500982,2500983,2706852,2706892,2009425,2500420,2501392, 2603200,2807685,2501550,2501315,2706332,2604191,2604217,2706407,2603757, 2603028,2603031,2501324,2300253,2300252,2603975,2704883,2603976,2807640, 2808342,2707351,2602872,2808599,2706811,2707210,2500216,2501543,2808299, 2808816,2100010,2807695,2009697,2500686,2604024,2705191,2808911,2808139, 2602993,2705168,2500369,2500602,2501796,2705522,2009502,2808909,2808836, 2601829,2601832,2807758,2707152,2808449,2501699,2601820,2501213,2200069, 2808356,2704854,2704864,2603401,2704735,2603647,2705203,2808490,2501463, 2602027,2705832,2501166,2603137,2603106

Product: Olympus, Model No. CF-Q160AL, flexible scope, large diameter, video colonoscope

Serial Numbers: 2427253,2528563,2315445,2314847,2212887,2315826,2000027,2314864,2315955, 2213834,2212872,2315727,2315729,2213866,2416648,2427952,2416195,2314929, 2111326,2416125,2213186,2111744,2315611,2213344,2314241,2427731,2427747, 2314885,2314876,2314596,2010689,2314038,2315864,2010526,2315138,2315140, 2315540,2111669,2212839,2212640,2427816,2314895,2427562

Product: Olympus, Model No. CF-140L, flexible scope, large diameter, video colonoscope

Serial Numbers: 2127866,2712435,2914674,2026893,2916216,2813792,2228261,2711888,2600329

Product: Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope

Serial Numbers: 2407409,2407584,2306291,2204284,2305898,2406901,2306874,2000549,2203971, 2407393,2203790,2000405,2306456,2102668,2203672,2406988,2102128,2103100, 2103035,2204108,2204527,2000464,2204116,2102323,2417865,2102954,2519556, 2418512,2306371,2305350,2407684,2519174,2519207,2519210,2102734,2205217, 2001322,2418634,2406987,2418156,2305446,2204190,2204202,2103307,2101785, 2518969,2519343,2102896,2203946,2001430,2305568,2102316,2305870,2204258

Product: Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope

Serial Numbers: 2201503,2000062,2000105,2100621,2301997,2100999,2201555,2302025,2000061, 2201491,2000039,2100930,2402518,2302084,2100852,2101121

Product: Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope

Serial Numbers: 2600297,2601232,2600397,2013906

Product: Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope

Serial Numbers: 2700328,2912416,2811408

Product: Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope

Serial Number 2303917

Product: Olympus, Model No. CF-Q140L, flexible scope, large diameter, video colonoscope

Serial Numbers: 2913081,2600279

Product: Olympus, Model No. XCF-Q160ALE, flexible scope, large diameter, video colonoscope

Serial Number 240T024

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 73088
Status: Resolved
Manufacturer: Integrated Medical Systems Inc
Manufactured In: United States
Units Affected: 22 products (190 instruments; 275 instruments; 232 instruments; 111 instruments; 180 instruments; 185 instruments; 21 devices; 82 instruments; 5 instruments; 26 instruments; 9 instruments; 12 instruments; 122 instruments; 43 instruments; 9 instruments; 54 instruments; 16 instruments; 4 instruments; 3 instruments; 1 instrument; 2 instruments; 1 instrument)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.